Executive Process Development (TT)

Lupin; Pithampur; On-site; INR 3,200,000 - 4,600,000; Full time

Job summary

Lupin Limited in Pithampur, Madhya Pradesh, invites an experienced professional to join Process Development. The Executive, Technology Transfer, will lead tech transfer activities from R&D to manufacturing, plan scale-up batches, review protocols, and ensure compliance with cGMP and regulatory expectations.

You will coordinate with R&D, Manufacturing, and quality teams, manage change controls, deviations, CAPA, and support audits while driving process improvements and timely product launches.

Qualifications

• 7–8 years of experience in formulation tech transfer / process development.
• M. Pharm or B. Pharm degree required.
• Strong knowledge of cGMP and regulatory filings.

Responsibilities

• Support technology transfer of drug products from R&D to the manufacturing site, and from one site to another.
• Plan and execute experimental, processed/unprocessed placebo, scale-up, pre-validation, exhibit and qualification batches.
• Prepare and review batch protocols and reports for experimental, scale-up and pre-validation batches.
• Review master BMR/BMI, process qualification protocols and reports, and RM, IP and FP specifications.
• Prepare and review elemental impurity and nitrosamine risk assessment reports.
• Review hold time studies, APQR, transportation studies, equipment qualification and cleaning validation documents.
• Review stability protocols for exhibit, commercial and development batches.
• Initiate SAP input data requests (BOM/Recipe) for placebo, exhibit and commercial batches.
• Coordinate with R&D, Manufacturing and GSCO/GSCM so that RM/PM are available on time.
• Handle QAMS: change controls, deviations and CAPA.
• Review investigations for OOS, OOT, OOE, IPOOS, deviations and market complaints.
• Support regulatory audits and inspections, and audit compliance.
• Contribute to process improvement projects, yield proposals and process flow charts.
• Provide complete documentation to QC, QA and RA for tech transfer, regulatory filing and product launch.
• Follow cGMP, GDP and EHS requirements, and complete training on relevant SOPs.

Skills

Formulation tech transfer

Process development

Regulatory support

QA/QC coordination

Education

M. Pharm / B. Pharm

Job description

Job Title: Executive Process Development (Technology Transfer)

Company: Lupin Limited

Department: Process Development

Location: Pithampur (Indore), Madhya Pradesh

Experience: 7 to 8 years in formulation tech transfer / process development

Qualification: M. Pharm / B. Pharm

Key Responsibilities:

• Support technology transfer of drug products from R&D to the manufacturing site, and from one site to another.
• Plan and execute experimental, processed/unprocessed placebo, scale-up, pre-validation, exhibit and qualification batches.
• Prepare and review batch protocols and reports for experimental, scale-up and pre-validation batches.
• Review master BMR/BMI, process qualification protocols and reports, and RM, IP and FP specifications.
• Prepare and review elemental impurity and nitrosamine risk assessment reports.
• Review hold time studies, APQR, transportation studies, equipment qualification and cleaning validation documents.
• Review stability protocols for exhibit, commercial and development batches.
• Initiate SAP input data requests (BOM/Recipe) for placebo, exhibit and commercial batches.
• Coordinate with R&D, Manufacturing and GSCO/GSCM so that RM/PM are available on time.
• Handle QAMS: change controls, deviations and CAPA.
• Review investigations for OOS, OOT, OOE, IPOOS, deviations and market complaints.
• Support regulatory audits and inspections, and audit compliance.
• Contribute to process improvement projects, yield proposals and process flow charts.
• Provide complete documentation to QC, QA and RA for tech transfer, regulatory filing and product launch.
• Follow cGMP, GDP and EHS requirements, and complete training on relevant SOPs.